In response to the rising complexity and cost of clinical trials, the industry is shifting towards the adoption of Risk-Based Monitoring (RBM) approaches. RBM promises to improve both clinical trial efficiency and data quality. A major challenge to implementing RBM is overcoming perceived complexity and determining roles and responsibilities for all stakeholders.
Explore a day-in-the-life of a team responsible for successfully planning and executing RBM, revealing how you can lead your organization’s RBM journey.
We will review with you the growing evidence in favor of risk-based monitoring, and how to take, what on the surface appears complicated, and make it simple.
- Understand the benefits from an integrated EDC, Targeted SDV, and centralized analytics/KRIs
- Learn best practices for RBM study planning and execution, and key pitfalls to avoid
- Draw a clear line of sight between study risk assessment and operational KRIs and quality oversight methods
- Capitalize on the best use of statistics in central data review
- Differentiate between KRIs and data quality assessment